Devices, methods, and systems for shrinking tissues

ABSTRACT

Devices, systems, and method for treating urinary incontinence generally relying on energy delivered to a patient&#39;s own pelvic support tissue to selectively contract or shrink at least a portion of that pelvic support tissue so as to reposition the bladder. The energy will preferably be applied to the endopelvic fascia and/or an arcus tendineus fascia pelvis. A variety of devices and methods are provided for applying gentle resistive heating of these and other tissues to cause them to contract without imposing significant injury on the surrounding tissue structures. By applying sufficient energy over a predetermined time, the tissue can be raised to a temperature which results in contraction without significant necrosis or other tissue damage. By selectively contracting the support tissues, the bladder neck, sphincter, and other components of the urinary tract responsible for the control of urinary flow can be reconfigured or supported in a manner which reduces urinary leakage.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.08/910,370 filed Aug. 13, 1997 (now U.S. Pat. No. 6,091,995); which is acontinuation-in-part of U.S. patent application Ser. No. 08/862,875,filed May 23, 1997; and which is a continuation-in-part of U.S. patentapplication Ser. No. 08/748,527, filed Nov. 8, 1996; the fulldisclosures of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to medical devices, methods, andsystems. In a particular aspect, the present invention provides devices,methods, and systems for shrinking tissues, and which are particularlyuseful for treatment of urinary incontinence in a laparoscopic orminimally invasive manner.

Urinary incontinence arises in both women and men with varying degreesof severity, and from different causes. In men, the condition occursalmost exclusively as a result of prostatectomies which result inmechanical damage to the sphincter. In women, the condition typicallyarises after pregnancy where musculoskeletal damage has occurred as aresult of inelastic stretching of the structures which support thegenitourinary tract. Specifically, pregnancy can result in inelasticstretching of the pelvic floor, the external vaginal sphincter, and mostoften, the tissue structures which support the bladder and bladder neckregion. In each of these cases, urinary leakage typically occurs when apatient's intra-abdominal pressure increases as a result of stress, e.g.coughing, sneezing, laughing, exercise, or the like.

Treatment of urinary incontinence can take a variety of forms. Mostsimply, the patient can wear absorptive devices or clothing, which isoften sufficient for minor leakage events. Alternatively oradditionally, patients may undertake exercises intended to strengthenthe muscles in the pelvic region, or may attempt behavior modificationintended to reduce the incidence of urinary leakage.

In cases where such non-interventional approaches are inadequate orunacceptable, the patient may undergo surgery to correct the problem. Avariety of procedures have been developed to correct urinaryincontinence in women. Several of these procedures are specificallyintended to support the bladder neck region. For example, sutures,straps, or other artificial structures are often looped around thebladder neck and affixed to the pelvis, the endopelvic fascia, theligaments which support the bladder, or the like. Other proceduresinvolve surgical injections of bulking agents, inflatable balloons, orother elements to mechanically support the bladder neck.

Each of these procedures has associated shortcomings. Surgicaloperations which involve suturing of the tissue structures supportingthe urethra or bladder neck region require great skill and care toachieve the proper level of artificial support. In other words, it isnecessary to occlude the urethra or support the tissues sufficiently toinhibit urinary leakage, but not so much that normal intentional voidingof urine is made difficult or impossible. Balloons and other bulkingagents which have been inserted can migrate or be absorbed by the body.The presence of such inserts can also be a source of urinary tractinfections.

For these reasons, it would be desirable to provide improved devices,methods, and systems for treating fascia, tendons, and other supporttissues which have been strained, or which are otherwise too long toprovide the desired support. It would be especially desirable to provideimproved methods for treating urinary incontinence in men and women. Inparticular, it would be desirable to provide methods for treatingurinary incontinence in a minimally invasive manner with few or nopercutaneous tissue penetrations, preferably utilizing laparoscopic orleast invasive manner to minimize patient trauma. It would further bedesirable to provide incontinence treatment methods which rely on theexisting bladder support structures of the body, rather than dependingon the specific length of an artificial support. It would also bedesirable to provide methods which rely on introduction of a relativelysimple probe into the urethra or vaginal, where tissue structuressupporting or comprising the urethra may be caused to partially shrinkin order to inhibit urinary leakage.

2. Description of the Background Art

Method and apparatus for controlled contraction of soft tissue aredescribed in U.S. Pat. Nos. 5,569,242, and 5,458,596. An RF apparatusfor controlled depth ablation of soft tissue is described in U.S. Pat.No. 5,514,130.

A bipolar electrosurgical scalpel with paired loop electrodes isdescribed in U.S. Pat. No. 5,282,799. U.S. Pat. No. 5,201,732 describesa bipolar sphincterotomy utilizing side-by-side parallel wires. Adisposable electrosurgical instrument is described in U.S. Pat. No.4,311,145. U.S. Pat. No. 5,496,312, describes an impedance andtemperature generator control.

The following patents and published applications relate to the treatmentof urinary incontinence. U.S. Pat. Nos. 5,437,603; 5,411,475; 5,376,064;5,314,465; 5,304,123; 5,256,133; 5,234,409; 5,140,999; 5,012,822;4,994,019; 4,832,680; 4,802,479; 4,773,393; 4,686,962; 4,453,536;3,939,821; 3,926,175; 3,924,631; 3,575,158; 3,749,098; and WO 93/07815.

An electrosurgical probe for the controlled contraction of tissues ofthe joints and for dermatological indicators is described in U.S. Pat.No. 5,458,596. A bipolar electrosurgical probe having electrodes formedover a restricted arc of its distal end for treatment of, e.g., theesophagus, is described in U.S. Pat. No. 4,765,331. An electrosurgicalprobe for retrograde sphincterotomy is described in U.S. Pat. No.5,035,696. Other patents describing electrosurgical probes include U.S.Pat. Nos. 5,462,545; 5,454,809; 5,447,529; 5,437,664; 5,431,649;5,405,346; 5,403,312; 5,385,544; 5,370,678; 5,370,677; 5,370,675;5,366,490; 5,314,446; 5,309,910; 5,293,869; 5,281,218; 5,281,217;5,190,517; 5,098,429; 5,057,106; 4,807,620; 4,776,344; 4,409,453; and373,399.

The disclosure of the present application is related to co-pending U.S.patent application Ser. No. 08/610,911, filed on Mar. 5, 1996, having acommon inventor but assigned to a different entity.

SUMMARY OF THE INVENTION

The present invention provides improved devices, methods, and systemsfor shrinking collagenated tissues, and particularly for treatingurinary incontinence. In contrast to prior art methods, the presentinvention does not rely on implantation of balloons or other materials,nor does it rely on suturing, cutting, or other direct surgicalmodifications to the genitourinary support tissues. Instead, the presentinvention relies on delivering energy to a patient's own pelvic supporttissue to selectively contract or shrink at least a portion of thatpelvic support tissue, thereby raising the position of the bladder. Theenergy will preferably be applied across bipolar electrodes to theendopelvic fascia and/or the arcus tendineus fascia pelvis. A variety ofdevices and methods are provided for applying gentle resistive heatingto these tissues without significant injury to the support tissues, orto the surrounding tissue structures.

In a first aspect, the present invention provides a probe for heatingand contracting fascia. The probe comprises a shaft having a proximalend and a distal end. First and second electrodes are disposed near thedistal end of the shaft. These electrodes are simultaneously engageableagainst the fascia, and are separated by a predetermined distance whichlimits a depth of tissue heating. A handle is adjacent to the proximalend of the shaft for manipulating the electrodes from outside thepatient body.

The bipolar probes of the present invention will generally include apredetermined electrode diameter and electrode separation distance tolimit the depth of tissue heating, and will optionally have atemperature sensor mounted between the electrodes. The probe will oftenbe adapted to heat the fascia to temperatures significantly less thanmost known electrosurgical devices, and may include a control systemwhich limits the total electrical potential applied between the bipolarelectrodes to much lower average power levels than known electrosurgicaldevices. In fact, the present heating probe may be convenientlyenergized with a battery pack carried in the proximal handle of theprobe.

In another aspect, the present invention provides a least invasive probefor heating and contracting fascia of a patient body. The fascia isadjacent to a tissue layer, and the probe comprises a shaft havingproximal and distal ends. An electrode is disposed near the distal endof the shaft and is laterally deployable from a narrow configuration toa wide configuration between the fascia and the adjacent tissue layer.The electrode in the wide configuration is exposed to engage the fascia.The electrode in the narrow configuration is disposed along an axis ofthe shaft to facilitate axial insertion of the probe. A handle isadjacent the proximal end of the shaft for manipulating the electrodefrom outside the patient body.

In yet another aspect, the present invention provides a probe forheating and contracting target tissues. The probe comprises a shafthaving a proximal end and a distal end. At least one electrode isdisposed near the distal end of the shaft. A handle is disposed adjacentthe proximal end of the shaft for manipulating the at least oneelectrode from outside the patient body. The handle supports a batteryand circuitry for energizing the at least one electrode with sufficientRF electrical potential to heat and contract the target tissue.

Circuitry for converting a direct current to an alternating current willoften be coupled to the battery to provide heating while avoiding nerveand/or muscle stimulation. In many embodiments, a control system will becoupled to the electrode so that the target tissue is raised to atemperature within a predetermined range. The temperature of the targettissue may be determined by a tissue temperature sensor disposed nearthe electrode (ideally being disposed between bipolar electrodes) and/orby monitoring the impedance, resistance, or other electricalcharacteristics of the tissue/electrode circuit.

In another embodiment, the present invention provides a probe forshrinking collagenated tissue of a patient body. The probe comprises ashaft having a proximal end and a distal end. A grasper is disposed nearthe distal end of the shaft, and is adapted to draw a region of thetissue inward so as to reduce tension within the region. An energyapplying member is disposed adjacent to the grasper. The energy applyingmember is capable of heating the tissue while the tension is reduced sothat the tissue contracts, but without substantially ablating thetissue.

The present invention also provides a method to treat a hyperextendingsupport tissue of a patient body. The hyperextending tissue has a tissuedepth, and the method comprises electrically coupling the firstelectrode to the hyperextending tissue. A second electrode is alsoelectrically coupled to the hyperextending tissue, and an electricalpotential is applied across the electrodes while controlling aseparation between the first and second electrodes. As a result of thisseparation control, an electrical current within the hyperextendingtissue heats and shrinks the hyperextending tissue, but heating oftissue beyond the tissue depth is minimized.

The present invention also provides a method to treat urinary stressincontinence. The method comprises introducing a probe into a patientbody and aligning the probe with a pelvic support tissue within thepatient body. The probe is energized to heat and contract a portion ofthe pelvic support tissue.

In most embodiments, a portion of the pelvic support tissue is gentlyand resistively heated to between about 60° C. and 110° C., often beingbetween about 60° C. and 80° C., by applying an electrical potentialacross the electrodes, the electrodes being adapted to engage the fasciasurface. This gentle bipolar resistive heating will often be targeted atfascia. Such contraction of the fascia can raise and/or reposition thebladder within the patient body when the fascia is heated to a depth ofless than about 2.8 mm, preferably to a depth of less than about 2.0 mm,thereby minimizing collateral injury to the surrounding tissues. Theheating depth can be precisely limited by controlling the diameter ofthe electrode surfaces (electrode surface diameter typically in therange from about 0.25 mm to about 4.0 mm, often being from about 0.25 mmto about 2.0 mm) and the ratio of the spacing between the electrodes tothe electrode surface diameter (the spacing typically being betweenabout 1.0 and 4.0 times the surface diameter). Advantageously, apreferred separation distance of between about 2 and 3 times theelectrode surface diameters will provide an effective heating depth ofabout 2 times the electrode surface diameter. Surprisingly, sufficientRF energy for such targeted heating can be provided by a battery packwithin a handle of the probe, the battery typically providing betweenabout 5 and 20 watts.

In a second aspect, the present invention provides an endoscopic methodfor treating urinary stress incontinence. The method comprisesintroducing a probe into a patient body, and optically imaging the probeand a target tissue. The target tissue comprises a portion of anendopelvic fascia or an arcus tendineus fascia pelvis. The electrode ispositioned against the target tissue, and energized to heat and contractthe target tissue, without substantially ablating the target tissue.

Once again, heating will often be limited in depth through the use of abipolar probe having a predetermined electrode diameter, spacing betweenthe electrodes, and power. Heating can be monitored and/or controlled,optionally using feedback from a temperature sensor mounted between theelectrodes. Advantageously, repeatedly sweeping the electrodes acrossthe endopelvic fascia can raise the bladder by discrete increments,typically by between about 0.1 and 3.0 mm with each sweep of theelectrodes.

In another aspect, the present invention provides a least invasivemethod for controllably shrinking fascia. The method comprises insertinga probe into a patient body while the probe is in a narrowconfiguration. The probe has first and second electrodes, and isexpanded to a wider configuration to deploy at least one of the firstand second electrodes. The deployed electrodes are engaged against thefascia, and an electrical potential is applied across the electrodes toheat and contract the fascia disposed therebetween.

In yet another aspect, the present invention provides a method fortreating a hernia. The hernia comprises a structure which protrudesthrough a containing tissue. The method comprises applying sufficientenergy to the containing tissue adjacent the hernia to heat thecontaining tissue so that the containing tissue contracts. Thecontraction mitigates the hernia, but the heat does not substantiallyablate the containing tissue.

In another aspect, the invention provides an abdominoplasty method fortightening an abdominal wall. The abdominal wall comprises a fascia, andthe method comprises applying sufficient energy to the abdominal wall toheat the fascia so that the abdominal wall contracts. The heat isapplied without substantially ablating the abdominal wall and adjacenttissues.

In yet another aspect, the invention provides a method to treat ahyperextending collagenated support tissue of a patient body. The methodcomprises grasping a region of the hyperextending tissue and drawing thehyperextending tissue inward so as to decrease tension in the region. Atleast a portion of the drawn region is heated so that the regionshrinks, wherein the region is heated without substantially ablating thehyperextending tissue.

In yet another aspect, the invention provides a kit for shrinking atarget collagenated tissue within a patient body. The target tissue hasa tissue depth, and the kit comprises a probe and instructions foroperating the probe. The probe includes a shaft having a proximal endand a distal end. First and second electrodes are disposed near thedistal end of the shaft, the electrodes defining a separation distancetherebetween. The instructions include the steps of electricallycoupling the first and second electrodes with the target tissue, andheating and contracting the target tissue without ablating the targettissue by directing an electrical current flux through the target tissuebetween the electrodes. The separation distance substantially limitsheating beyond the target tissue depth.

In yet another aspect, the invention provides a kit for treating urinarystress incontinence of a patient with a lax pelvic support structure.The kit comprises a probe having a heating element and instructions foroperating the probe. Instructions include the steps of coupling theheating element to the pelvic support structure, and applying an amountof energy with the heating element to the pelvic support structure. Theenergy is sufficient to cause shrinkage of the pelvic support structure,and the shrinkage inhibits urinary incontinence.

In yet another aspect, the invention provides a kit for treating ahernia. The hernia comprises a structure which protrudes through acollagenated containing tissue. The kit comprises a probe having aheating element and instructions for operating the probe. Theinstructions include the steps of coupling the probe to the containingtissue, and applying an amount of energy from the probe to thecontaining tissue. The energy is sufficient to heat the containingtissue so that the containing tissue shrinks to mitigate the hernia.

In one exemplary embodiment of the present method, energy is appliedfrom within the patient's urethra, typically by inserting anenergy-applying probe into the urethra without having to employ anypercutaneous or transmucosal penetrations or incisions. When using sucha urethral probe, the energy will typically be applied directly to theurethral wall, either to a single location aligned with the urethralsling or to at least two sites including a first site upstream of theurethral sling and a second site downstream of the urethral sling. By“urethral sling,” we mean those supporting tendons and other tissuestructures which extend from the pubic bone downward beneath the urethraand urethral sphincter. Application of energy at such location(s) actsto shrink tissue adjacent the urethral lumen and to provide selective“kinks” or closure points at which the urethra can be closed.

In an alternative exemplary embodiment, energy-applying elements arepenetrated directly into the pubococcygeal muscles, the iliococcygealmuscles, and/or detrusor urinae muscles (and adjacent fascia) whichsupport the urethra and urinary sphincter. By applying energy directlyinto these supporting muscles and tissue structures, the muscles can becontracted to provide improved urinary continence. In particular,sufficient muscular integrity can be provided so that urinary leakagedoes not result from transient increases in intra-abdominal pressure asa result of stress. In the illustrated embodiment, the electrodes arepenetrated into the target muscles through the vagina, typically usingan introducer having an array of extensible electrodes arranged tocontact the target muscles and/or tendons.

In these exemplary embodiments, the energy will typically be appliedusing an electrode capable of delivering radio frequency (RF) energydirectly against the urethral wall or into the supporting tissues in amonopolar or bipolar manner. In the first embodiment, electrodes willusually be surface electrodes, i.e., adapted to contact the luminal wallof the urethra without penetration. In the second embodiment, theelectrodes are fashioned as needles or other penetrating members whichcan penetrate into the urethral wall by a desired distance. In additionto electrodes, the heat-applying elements can be optical fibers (fordelivery laser or other light energy), resistive heating elements,inductive heating elements, microwave heating elements, or any otherdevice which can be externally powered to heat tissue to thetemperatures and for the times discussed below.

The methods of the present invention may also be performed using devicesand systems which access the treated tissue structures from sites otherthan the urethra or vagina. For example, energy-applying probes can beintroduced percutaneously from the patient's abdomen to a desiredtreatment site, for example the pubococcygeal muscle and tendon, or mayalternatively be introduced through the rectum. Alternatively, in femalepatients, the energy-applying probes can be transmucosally introducedthrough the vagina, as discussed above. For the purposes of the presentinvention, it is necessary only that the energy be delivered to a targettissue structure in a manner which permits heating of the tissue to adesired temperature and for time sufficient to contract the tissue by adesired amount.

In addition to RF energy, the devices, systems, and methods of thepresent invention can rely on other energy sources, such as microwave,light (laser) energy, electrical resistance heating, the delivery ofheated fluids, the focusing of ultrasound energy, or any other knownenergy delivery technique which can be targeted to specific tissue andraise the tissue temperature to the desired range.

When energy is applied directly to the luminal wall, it will bedesirable to control the resulting cross-sectional area of the urethra.Usually, the cross-sectional area will be reduced. Control of the amountof reduction can be effected, for example, by placing theenergy-applying elements, such as RF electrodes, on an expandable memberwhich can initially be expanded to contact the elements against theluminal wall. As the luminal wall shrinks, the cross-section area of theexpandable member can also be reduced. Alternatively, in instances wherethe energy is being applied to contract adjacent tissue structures, itmay be necessary to further expand the expandable member carrying theelectrodes to maintain contact. A variety of specific configurations canbe utilized.

In some embodiments, devices according to the present invention willcomprise a probe body having a proximal end and a distal end. The bodywill preferably have a length and diameter selected to permitintroduction into the urethra or vagina so that the distal end can bepositioned adjacent to the urethral sling or target tissues. One or moreelectrodes are disposed on the distal end of the probe body to applyenergy into the urethral wall in the region of the urethral sling and/orinto the tissue structures which support the urethral sling. A connectoris provided on the proximal end of the probe body to permit connectionto an appropriate power supply. The probe body will typically have alength in the range from 5 cm to 20 cm with electrode lengths in therange from 0.3 cm to 7 cm. The probe body will usually have a diameterin the range from 1 mm to 6 mm. The body will usually be flexible, butcould also be rigid. The body should have sufficient torsional rigidityto permit rotational orientation and alignment of the probe within theurethra. The probe will include at least a single electrode, and willoften include two or more electrodes which can be connected to the powersupply in a monopolar or a bipolar fashion. The electrodes may besurface electrodes (for engaging the urethra wall) or tissue-penetratingelectrodes for applying energy into the urethra-supporting tissues. In aspecific embodiment, the probe will include two axially-spaced apartelectrodes which are positioned and configured so that they will bealigned on the upstream and downstream sides of the urethral sling whenapplying energy within the urethra. The probe may further comprise anexpansion member, such as an expandable balloon, carrying at least oneof the electrodes on the catheter body. In a second specific embodiment,the probe includes an array of extensible, tissue-penetration electrodesdisposed to penetrate target tissues from the vagina.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a bipolar battery operated probe forlaparoscopically heating and contracting fascia, according to theprinciples of the present invention.

FIG. 2 is a schematic of the functional components of the probe of FIG.1.

FIG. 3 is a lateral cross-sectional view showing the urinary bladder andbladder support structures.

FIG. 4 is a simplified cross-sectional view of the pelvis showing theendopelvic fascia and arcus tendineus fascia pelvis, and illustrates amethod for treating urinary stress incontinence by sweeping the probe ofFIG. 1 across the endopelvic fascia to reposition and/or raise theurinary bladder.

FIG. 5 is a cross-sectional view of a patient suffering from urinarystress incontinence due to inelastic stretching of the endopelvicfascia.

FIG. 6 shows a known method for treating urinary stress incontinence byaffixing sutures around the bladder neck.

FIG. 7 illustrates improved bladder support provided by selectivelycontracting the endopelvic fascia as a therapy for urinary stressincontinence, according to the principles of the present invention.

FIG. 7A illustrates a patient suffering from a cystocele in which thebladder protrudes into the vagina, and which may be treated byselectively contracting the pelvic support tissues using the methods ofthe present invention.

FIG. 8 illustrates how the controlled spacing between the bipolarelectrodes of the probe of FIG. 1, relative to the electrode diameter,limits the depth of tissue heating.

FIG. 9 schematically illustrates repeatedly sweeping the bipolarelectrodes of the probe of FIG. 1 across the endopelvic fascia to raisethe urinary bladder in a series of discrete increments.

FIGS. 10-12D illustrate alternative electrode configurations for usewith the probe of FIG. 1.

FIGS. 13A and 13B illustrate bipolar electrodes which move relative toeach other when tissue contracts to provide feedback and/or limit tissueheating, according the principle of the present invention.

FIG. 13C illustrates an electrode structure that varies the heatingdepth with the rotational position of the probe about the axis of theprobe.

FIG. 14 illustrates a bipolar fascia contracting probe having rollerelectrodes to facilitate sweeping the probe over the fascia.

FIG. 15 illustrates a joystick actuated least invasive probe forpenetrating through the vaginal mucosa to the mucosa/fascia interface,the endopelvic fascia surface, or the vesical-vaginal space, the probehaving an asymmetric handle to indicate the electrode orientation,according the principles of the present invention.

FIGS. 15A-15D illustrate least invasive methods for accessing theendopelvic fascia through the vaginal mucosa or the bladder wall.

FIG. 16 illustrates an asymmetric least invasive probe having bipolarelectrodes which are deployable by inflating a balloon.

FIGS. 17A and 17B schematically illustrate self-orientation of theinflatable electrode assembly of the probe of FIG. 16.

FIGS. 18A and 18B schematically illustrate the deployment of bipolarelectrodes by inflating an asymmetric flat balloon with two differentinflation media to radiographically verify the orientation of theelectrodes.

FIG. 19 illustrates the deployed state of an alternative balloondeployable electrode configuration for use with the least invasive probeof FIG. 15.

FIGS. 20A-20C schematically illustrate the deployed state of a balloonhaving alternating electrodes, and a method for its use to separate afascia targeted for contraction from an adjacent tissue surface, afterwhich the balloon is partially deflated for heating and contracting thefascia.

FIGS. 21A and 21B schematically illustrate bipolar electrodes which aresupported along resilient elongate structures, in which the elongatestructures are biased to separate the electrodes, for use with the leastinvasive probe of FIG. 15.

FIGS. 22A-22C schematically illustrate an alternative electrodedeployment structure in which a pull-wire deflects elongate structuresto deploy the electrodes.

FIGS. 23A-23C schematically illustrate an electrode deployment structurein which a central member is tensioned to deflect the electrode supportstructures resiliently outwardly.

FIG. 24 is a perspective view of an alternative probe for shrinkingendopelvic fascia and other collagenated tissues, in which the probeincludes a grasper which reduces tension in the region of tissue to becontracted to enhance shrinkage.

FIGS. 25A and 25B schematically illustrate a method for using the probeof FIG. 24 by grasping the target tissue and drawing a region of thetarget tissue inward to reduce tension in the engaged tissue, andthereby enhance shrinkage.

FIGS. 26-26C are cross-sectional views of a patient suffering from ahiatal hernia showing a method for treatment using the probes of thepresent invention.

FIG. 27 illustrates a patient suffering from an inguinal hernia, andidentifies regions for treating the inguinal hernia using the methods ofthe present invention.

FIG. 28 is a perspective view of an exemplary electrosurgical probeconstructed in accordance with the principles of the present invention.

FIGS. 28A-28D illustrate alternative electrode configurations for theprobe of FIG. 28.

FIG. 29 illustrates a distal probe tip having an expandable ballooncarrying an electrode array.

FIG. 30 illustrates a system comprising the probe of FIG. 28 and a powersupply performing a procedure in a patient's urethra.

FIG. 31 illustrates a second exemplary electrosurgical probe constructedin accordance with the principles of the present invention.

FIG. 32 is a detailed distal end view of the probe of FIG. 31.

FIG. 33 is a detailed distal side view of the probe of FIG. 31.

FIGS. 34-37 illustrate the use of the probe of FIGS. 31-33 in performinga procedure in a patient's vagina.

FIG. 38 schematically illustrates a kit including a laparoscopic tissuecontraction probe, packaged together with pointed instructions for itsuse to contract tissue as a treatment for urinary incontinence.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

The present invention generally provides devices, methods, and systemswhich can selectively shrink fascia and other collagenated tissues. Bydirecting an electrical current flux through such a tissue, ideallybetween bipolar electrodes directly engaging the tissue, the electricalresistance of the tissue can induce gentle heating and contraction ofthe tissue without significant injury to the adjacent tissues.Controlling a diameter of the electrode surfaces and a ratio of thesurface diameter to a separation distance between the electrodes canlimit the depth of heating, while electrode surface shape and size willhelp determine heating at the electrode/tissue interface. The presentinvention is particularly well adapted for contraction of fascia andligaments, and may therefore have applications in a variety oftherapies, including traditional and minimally invasive therapies of thepelvis, thorax, and joints. These devices, methods, and systems areadaptable for therapies of specific tissues and conditions includinghiatal hernias, abdominal hernias, cystocele, enterocele, rectocele, anduterovaginal prolapse. The present invention will find its mostimmediate application for the treatment of urinary stress incontinence.In many embodiments, the present invention will effect contraction of apelvic support tissue to raise a position of the bladder, particularlyafter the pelvic support tissues have been stressed by pregnancy.Related devices and methods are described in co-pending U.S. patentapplication Ser. No. 08/910,775 filed on Aug. 13, 1999, the fulldisclosure of which is incorporated herein by reference.

In general, the present invention is well adapted for treatment of anyhyperextending collagenated tissue. As used herein, the term“hyperextending” encompasses any tissue structure which is excessive inat least one dimension, so that a support function of the tissue iscompromised. This excessive length, etc., may be the result of injury,pregnancy, disease, age, a congenital defect, a tear or partial tear, orthe like.

Referring now to FIG. 1, a tissue contraction probe 10 includes a shaft12 having a proximal end 14 and a distal end 16. First and secondelectrodes 18, 20 are disposed near distal end 16 of shaft 12, while ahandle 22 is disposed at the proximal end of the shaft. A switch 24applies a radiofrequency electrical potential across first and secondelectrodes 18, 20 to effect gentle resistive heating of electricallyconductive tissues which span these electrodes. Surprisingly, powerrequirements of this targeted bipolar resistive heating are so low thata battery pack contained within handle 22 can sufficiently energizefirst and second electrodes 18, 20.

As can be understood with reference to FIG. 2, a battery pack 26energizes probe 10, typically providing a relatively low power radiofrequency current. The direct current of the battery is converted to thedesired radio frequency by a DC to AC converter of a RF generator 28.The electrical potential applied to first and second electrodes 18, 20will typically be between about 200 and 1,000 KHz, and will typicallyhave an amplitude of between about 10 and 100 volts ac rms. Such lowpower heating will substantially avoid arcing between the electrode andthe tissue surface, further decreasing the injury to these tissues, andalso providing safety to the operator. The RF electrical heating willalso desiccate the tissue, increasing its resistance. Since the appliedvoltage is too low to cause arcing, the delivered power will decrease asthe tissue dries, so the tissue damage is superficial and self limiting.This makes treatment less subject to operator error.

A heating controller 30 will often limit at least one of the following:the temperature of the target tissue, the shrinkage of the tissuebetween the electrodes, and/or the time the target tissue is maintainedat an elevated temperature. In some embodiments, tissue heatingtemperatures will be measured directly using a temperature sensor 32mounted to the probe between the first and second electrodes 18, 20, orseparately inserted into the tissue via an ultrasonically orfluoroscopically guided temperature probe. Alternatively, tissuetemperature, contraction, and the like may be determined indirectly bymonitoring the electrical characteristics of the tissue itself. In otherwords, by monitoring the circuit during heating, the tissue resistivity,resistance, capacitance, or the like, can be calculated. From thesevalues, and optionally by monitoring the changes in these electricalcharacteristics, it may be possible to estimate the temperature ordegree of desiccation of the tissue, the amount of shrinkage which hasoccurred, and the like. Preferably, controller 30 will limit the heatingof tissues to a temperature range of between about 60° C. and 110° C.,ideally to between about 60° C. and 80° C.

Alternatively, it may be possible to simply limit the electricalpotential applied across the electrodes thereby permitting normalthermal conduction to control the maximum temperature. In fact, in someembodiments, a simple timer may be coupled to switch 24, so that alimited amount of energy is applied across first and second electrodes18, 20, thereby avoiding over-treatment (particularly during spottreatments, as described hereinbelow). The physician simply energizesthe time limited circuit after each movement of the electrodes, therebyavoiding unintended over-treatment, and also helping to ensure thatsufficient energy is delivered for treatment of each site.

While the exemplary embodiment incorporates battery pack 26 andcontroller 30 into handle 22, it should be understood that theenergizing and control functions may be provided by structures which areexternal to probe 10. In such embodiments, couplers for connectingelectrodes 18 and 20 to a power source, control circuitry, and the like,will often be provided on housing 22. Battery pack 26 may optionallyinclude two or more batteries. As used herein, a battery may be a singlecell or a series of cells, where each cell is a substantiallyself-contained D.C. energy source.

The pelvic support tissues which generally maintain the position of theurinary bladder B are illustrated in FIG. 3. Of particular importancefor the method of the present invention, endopelvic fascia EF defines ahammock-like structure which extends between the arcus tendineus fasciapelvis ATFP, as can be understood with reference to FIG. 4, these latterstructures extend substantially between the anterior and posteriorportions of the pelvis, so that the endopelvic fascia EF largely definesthe pelvic floor.

In women with urinary stress incontinence due to bladder neckhypermobility, the bladder has typically dropped between about 1.0 and1.5 cm (or more) below its nominal position. This condition is typicallydue to weakening of the pelvic support structures, including theendopelvic fascia, the arcus tendineus fascia pelvis, and thesurrounding ligaments and muscles, often as the result of bearingchildren.

When a woman with urinary stress incontinence sneezes, coughs, laughs,or exercises, the abdominal pressure often increases momentarily. Suchpressure pulses force the bladder to descend still further, shorteningthe urethra UR and momentarily opening the urinary sphincter.

As can be most clearly understood with reference to FIGS. 3-7, thepresent invention generally provides a therapy which applies gentleheating to shrink the length of the support tissues and return bladder Bto its nominal position. Advantageously, the bladder is still supportedby the fascia, muscles, ligaments, and tendons of the original pelvicsupport tissues. Using gentle resistive heating between bipolarelectrodes, the endopelvic fascia EF and arcus tendineus fascia pelvisATFP are controllably contracted to shrink them and re-elevate thebladder towards its original position.

Tissue contraction with probe 10 will generally be performed in at leastone of two modes: spot treatments and line treatments. For example, byengaging the arcus tendineus fascia pelvis at a substantially fixedlocation with first and second electrodes 18, 20, a discrete portionalong that substantially linear structure can be gently heated for a fewseconds to the target temperature range. The tough fibrous tendon willthen shorten, raising the endopelvic fascia EF which, in turn, raisesthe overall position of bladder B. Such contractions of a discreteregion about a fixed engagement location are herein called spottreatments.

To provide a line treatment, the distal end of probe 10 is swept acrossendopelvic fascia EF laterally or linearly, as illustrated in FIG. 4. Asthe electrodes engage the adjacent endopelvic fascia, they raise thetemperature of the adjacent tissues, resulting in a line of contractedtissues behind and between the electrode paths. Advantageously, thisline of fascia contraction increases the overall tautness of theendopelvic fascia, again raising the overall position of bladder B. Thisis an example of the use of a single line treatment to effectrepositioning of the bladder.

Advantageously, repeatedly sweeping probe 10 across adjacent areas ofthe endopelvic fascia can raise the bladder in discrete increments. Forexample, if first and second electrodes 18, 20 are separated by a spaceof about 3.0 mm, and if the fascia shrinks by about 50% with it eachsweep of probe 10, the physician can re-elevate bladder B about 1.5 cmwith between 10 and 15 line treatments of the endopelvic fascia. Similarresults may be provided by 10 to 15 spot treatments of the arcustendineus fascia pelvis, or by some combination of spot and linetreatments.

Access to and direction of the therapy, as schematically illustrated inFIG. 4, will often be provided by the minimally invasive methods anddevices that have recently been developed. In many embodiments, alaparoscope 34 will allow direct optical imaging, often while the pelvicregion is distended using gas insufflation. The present methods may beoptically directed using a variety of existing endoscopic structures,depending on the treatment site and access approach. Laparoscopes,arthroscopes, hysteroscopes, or the like may be used (or adapted foruse) in the present methods. Alternatively, conventional optical imagingcapabilities may be incorporated into probe 10, or specialized fiberoptic image guides may be used, either separated from or incorporatedinto probe 10. In some embodiments, the therapy may be directed using aremote imaging modality, such as fluoroscopy, ultrasound, magneticresonance imaging, or the like. It is also possible to take advantage ofthe controlled tissue contraction of the present invention in a moretraditionally invasive therapy.

Referring now to FIG. 5, bladder B can be seen to have dropped from itsnominal position (shown in phantom by outline 36). While endopelvicfascia EF still supports bladder B to maintain continence when thepatient is at rest, a momentary pulse P opens the bladder neck Nresulting in a release through urethra UR.

A known treatment for urinary stress incontinence relies on sutures S tohold bladder neck N closed so as to prevent inadvertent voiding, as seenin FIG. 6. Sutures S may be attached to bone anchors affixed to thepubic bone, ligaments higher in the pelvic region, or the like. In anycase, loose sutures provide insufficient support of bladder neck N andfail to overcome urinary stress incontinence, while over-tightening ofsutures S may make normal urination difficult and/or impossible.

As shown in FIG. 7, by selectively contracting the natural pelvicsupport tissues, bladder B can be elevated from its lowered position(shown by lowered outline 38). A pressure pulse P is resisted in part byendopelvic fascia EF, which supports the lower portion of the bladderand helps maintain the bladder neck in a closed configuration. In fact,fine-tuning of the support provided by the endopelvic fascia is possiblethrough selective contraction of the anterior portion of the endopelvicfascia to close the bladder neck and raise bladder B upward.Alternatively, lateral repositioning of bladder B to a more forwardposition may be effected by selectively contracting the dorsal portionof endopelvic fascia EF. Hence, the therapy of the present invention maybe tailored to the particular weakening exhibited by a patient's pelvicsupport structures.

Another condition which is suitable for treatment using the methods ofthe present invention is illustrated in FIG. 7A. In this patient, aposterior portion PP of bladder B protrudes into vagina V so that anacute angle is formed by the posterior wall of the urethra and theanterior wall of the urinary bladder. Such a condition, generallyreferred to as cystocele, may be effectively treated by selectivelycontracting the endopelvic fascia and/or other pelvic support tissuesand repositioning the bladder as described above. Additional conditionswhich may be treated using the methods of the present invention includeenterocele (a hernial protrusion through a defect in the rectovaginal orvesicovaginal pouch), rectocele (prolapse or herniation of the rectum),and uterovaginal prolapse (downward movement of the uterus so that thecervix extends into or beyond the vaginal orifice, usually from injuriesduring childbirth or advanced age). For each of these conditions, themethods of the present invention generally make use of the naturalsupport tissues within the pelvis, generally by selectively contractingthose support tissues to reposition and/or contain the displaced organs.As will be described in more detail hereinbelow, herniated structuresmay be treated at least in part by repositioning the protrudingstructures behind the tissue which nominally contain them, and thenselectively contracting the containing tissues to prevent reoccurrenceof the hernia.

Referring now to FIGS. 8 and 9, a depth D of the endopelvic fascia EF(and adjacent tissue T) heated by bipolar probe 10 will depend on thepower applied, on a spacing S between first and second electrodes 18,20, and on the surface diameter 39 of the electrodes. Generally, spacingS will be between about 0.25 and 4.0 mm. More specifically, spacing Swill preferably be in the range from about 1 to 4 times the electrodediameter 39, with the electrode diameter often being between about 0.25and 4.0 mm, preferably being between about 0.25 and 2.0 mm, and ideallybeing between 0.25 and 1.0 mm. This will limit the heating depth D togenerally less than about 2.0 mm, and often to less than 1.0 mm.Advantageously, the temperature gradient along the edge of the treatmentzone is quite steep. By such selective heating of the endopelvic fasciaEF, collateral damage to the underlying tissues T is limited. Fasciawill contract when heat is applied by such a structure for a very shorttime, the target tissue ideally being heated for a time in a range fromabout 0.5 to 5 seconds. In general, selectively targeting the fasciaadjacent the surface maximizes the tissue contraction provided byheating, and greatly limits necrosis, lesioning, and other collateralinjuries to the vaginal mucosa and the muscular tissues which help tosupport the bladder in the desired position. As more fully explained inapplication Ser. No. 08/910,775 filed Aug. 13, 1997, the electrodes maybe cooled to prevent injury to the engaged tissue surface. Cooling maybe provided, for example, by forming the electrodes of thermallyconductive tubing, and by running a cold fluid through the tubing.

As illustrated in FIG. 8, a film 41 of saline, either natural orintroduced, may be disposed over the engaged tissue surface. Film 41prevents the electrode surfaces from sticking to the engaged tissue, andcan also provide a more even impedance and/or power through thecircuitry. Drying of the tissue surface due to CO₂ insufflation may beavoided by providing a saline irrigation of about 1 cc/min. during thetissue contraction procedure.

While spacing S will often be fixed, it should also be understood thatthe separation between the first and second electrodes may optionally bevaried to controllably vary the heating depth D.

The sweeping of first and second electrodes 18, 20 of probe 10 over theendopelvic fascia EF to discretely raise the bladder can be understoodwith reference to FIG. 9. The endopelvic fascia EF is heated andcontracted by the passing electrodes, the fascia typically contractingby an amount within the range between about 30 and 50%. As theelectrodes sweep across the fascia surface, they define electrode paths40. The electrode paths are closer together after probe 10 has swept by,so that the overall width of the endopelvic fascia decreases by anamount of between about 0.3 and 0.5 times electrode spacing S each timeprobe 10 sweeps over untreated fascia (in our example). Hence, the totaldistance that the bladder is raised can be varied by varying the numberof sweeps of probe 10. The probe will preferably sweep a differentsection of the endopelvic fascia each time, as fascia which haspreviously been contracted will undergo only a more limited contraction.Hence, probe 10 will often be moved axially by an amount of at least theelectrode spacing S prior to each sweep.

A variety of alternative electrode configurations are illustrated inFIGS. 10-12D. FIG. 10 illustrates a probe 42 which is otherwise similarto probe 10 of FIG. 1, but which includes first and second interleavedhelical electrodes 44, 46. These electrodes alternate about the distalend of helical probe 42 in a “barber pole” configuration. This allows agreater amount of shrinkage each time helical probe 42 engages a fasciaor ligament surface, as heating will be provided between each span ofthe tissue between adjacent electrodes, and also eliminates any need forangular alignment of the probe. Advantageously, spacing S remainssubstantially uniform over the probe surface.

Distally oriented probe tip 48 includes first and second distallyoriented electrodes 50, 52 which are again separated by spacing S. Thisstructure is particularly well-suited for contracting tissues havingsurfaces which are oriented normal to the axis of the probe, and forspot contraction of certain tissue bands (such as ligaments). Anaxially-ended probe tip 54 includes alternating first and secondaxially-ended ribbon or wire electrodes 56, 58, and is adapted forengaging both laterally and proximally oriented tissue surfaces. Notethat axial first and second electrodes 56, 58 may comprise ribbonstructures or wires which are inset into axially-ended electrode tip 54,thereby avoiding inadvertent engagement of tissues adjacent the targettissue surface. Sensor 32 optionally measures the temperature of thetarget tissue.

In some embodiments, the electrode structures on the probes of thepresent invention will provide feedback to the probe regarding theamount of tissue contraction. Referring now to FIG. 13A, a moveableelectrode probe 60 includes rotatable first and second electrodes 62, 64which roll about a shaft 66 to facilitate sweeping of the electrodesover the target surface. The electrodes also include radial protrusions,presenting a structure which looks somewhat like a gear with pointedteeth. The protrusions minimize sliding between the electrode surfaceand the target tissue surface. Hence, as the engaged tissue contractsalong the axis of shaft 66, it draws the first and second rotatableelectrodes 62, 64 together.

By measuring the displacement between first electrode 62 and secondelectrode 64, moveable electrode probe 60 provides an indication of thetotal tissue shrinkage. The attending physician or an electronicelectrode energizing control circuit may make use of this feedback tocontrol tissue heating. Alternatively, the probe may measure the forcethe contracting tissue imposes on the electrodes without allowing anyactual displacement of one electrode relative to the other. Such astructure would maintain the fixed spacing S between the electrodes.

An even simpler feedback mechanism is illustrated in FIG. 13B. Spotcontraction probe 70 includes first and second shortable electrodes 72,74 which will contact each other when the engaged tissue is contractedby a predetermined amount. The shorting of the electrodes will oftenprovide a signal terminating the energizing of the electrodes. Theelectrodes will optionally have protrusions 76 which press into thetissue surface to avoid sliding.

Those with skill in the art will realize a variety of mechanisms may beused to measure shrinkage of the tissue, including fiber optic measuringmechanisms, micro-switches, strain gauges, or the like. However, theelectrode structure illustrated in FIG. 13B has the advantage that theshorting of the electrodes automatically terminates heating, allowingthe device to both measure and control shrinkage with a very simplestructure.

In some embodiments, a variable spacing between first and second bipolarelectrodes may allow the surgeon to control the depth of heating. Forexample, as illustrated in FIG. 13C, rotating a variable spacing probe80 allows the physician to engage a target tissue surface with alternateportions of angled electrodes 82, 84 to vary an effective spacing EStherebetween. Note that local electrode surface diameters of angledelectrodes 82, 84 vary with separation, so that a ratio of electrodeseparation ES to local surface diameter remains about 2 to 1. Clearly,more complex spacing varying mechanisms are also possible.

A wide variety of alternative electrode structures are also possible.Referring now to FIG. 14, a still further alternative embodiment of thepresent laparoscopic or endoscopic probe 90 has first and secondpartially enclosed roller electrodes 92, 94 for rolling against tissuesurface without inadvertently engaging the surrounding tissues. Morethan two rollers may be used, with the polarity of the electrodesgenerally alternating (as can be understood with reference to FIGS.10-12B). Such alternating electrodes may instead be defined by axialwires or ribbons in a straight configuration, or may curve inalternating spirals at the distal end of the probe. In some embodiments,the electrodes may be defined by the ends of coaxial tubes withinsulating material between the tubes and over the outer tube.

While the shafts supporting the electrodes of the present invention aregenerally shown as straight structures, many of these embodiments mayalternatively incorporate bends in the shafts between the proximal anddistal ends. Alternatively, the shafts may be articulated to facilitateengaging the target tissue surface. Hence, the present inventionencompasses not only straight shafts, but shafts which are slanted,angled, articulated, flexible, inflatable, or the like, to facilitateengaging a target tissue from the selected approach position.

Referring now to FIG. 15, a least invasive probe 100 includes a distalneedle 102 to facilitate inserting an articulated shaft 104 and accessthe fascia supporting the pelvic floor. The device will typically gainaccess to this treatment site by percutaneous insertion through the skinof the abdomen, through the wall of the vagina, or through the urethra.A joystick 106 manipulates articulated shaft 104, which can facilitatepositioning the electrodes against the target tissue. Optionally,joystick 106 may also be used to direct needle 102 to penetrate thevagina mucosa or bladder surface.

Methods for accessing endopelvic fascia EF using least invasive probe100 are illustrated in FIGS. 15A-15C. Shaft 104 is inserted in thevagina and placed against the anterior surface. Needle 102 perforatesthe vaginal mucosa VM, optionally extending through endopelvic fascia EFto lay adjacent to (and in contact with) the endopelvic fascia betweenthe endopelvic fascia and bladder B in the vesical-vaginal space 101.Alternatively, needle 102 may be directed through vaginal mucosa VMwithout perforating endopelvic fascia EF to lay in contact with theendopelvic fascia between the endopelvic fascia and the vaginal mucosa.In either case, once least invasive probe 100 has accessed endopelvicfascia EF, one or more electrodes will engage and heat the fascia toinduce contraction. In some embodiments, a two-pronged needle probecould be used, with each needle having an electrode surface tofacilitate bipolar resistive heating. Alternatively, the needle may beremoved from the positioned least invasive probe 100 and replaced with adeployable electrode structure, as described hereinbelow.

FIG. 15D illustrates a still further alternative method for accessingendopelvic fascia EF. In this embodiment, a cystoscope 105 is insertedthrough urethra UR into bladder B. A curved needle 103 punctures throughthe bladder wall with a retrograde orientation, the needle preferablybeing clear of the ureteral vesical junctions and trigon. Curved needle103 is again positioned in contact with endopelvic fascia EF on theanterior surface of the vagina. Such a method may make use of anoff-the-shelf cystoscope.

Least invasive probe 100 will often be positioned using a remote imagingmechanism, typically in a fluoroscopically or ultrasonically directedprocedure. To help ensure that the electrodes of least invasive probe100 are properly oriented toward the target tissue, asymmetric handle108 will often be rotationally affixed relative to the electrode. Insome embodiments, electrodes may simply be positioned on the surface ofarticulatable shaft 104, on needle 102, or the like. However, tominimize the cross-section of 104 so as to facilitate percutaneousinsertion, it will often be advantageous to include an electrode supportstructure which is deployable from the shaft once the electrodes arepositioned adjacent the target surface. Such a deployable electrodestructure may optionally be inserted through articulated shaft 104 afterremoval of needle 102, or may instead be incorporated into the distalend of articulated shaft 104.

An example of a deployable electrode structure is illustrated in FIG.16. Balloon system 110 includes a shaft 112 having an angular positionindicating line 114. Line 114 helps to indicate the orientation of adistal balloon 116 from the proximal end of the balloon system. In otherwords, line 114 allows the physician to verify that first and secondballoon electrodes 118, 120 are properly oriented to engage the targettissue.

The use of balloon system 110 will be explained with reference to FIGS.16, 17A and 17B. Balloon 116 is inserted between the endopelvic fasciaEF and an adjacent tissue AT while the balloon system is in a narrowdiameter configuration. In the narrow configuration, balloon 116 isdeflated and the electrodes are disposed along shaft 112. Once thedeflated balloon is at the desired location, the balloon may be roughlyrotationally positioned with reference to line 114 on shaft 112. Balloon116 can then be inflated through inflation port 122 on proximal balloonhousing 124. As the balloon inflates, it separates endopelvic fascia EFfrom adjacent tissue AT. Additionally, as balloon 116 defines asubstantially flat structure when inflated, it will tend to self-orient,so that first and second balloon electrodes 118, 120 engage theendopelvic fascia as shown in FIG. 17B.

In some embodiments, balloon 116 is bilaterally asymmetric to helpverify the orientation of the deployed electrodes. The asymmetricfeature of balloon 116 may comprise simple radiopaque or ultrasonicallyimageable markers, differing first and second electrode shapes, or thelike. In the embodiment illustrated in FIG. 17B, the balloon isasymmetrically mounted to shaft 112. When viewed under fluoroscopy,ultrasound, or the like, this asymmetry helps verify the position andorientation of the electrodes.

Once the first and second balloon electrodes 118, 120 are positioned,the electrodes may be energized through electrical coupler 126. A thirdconnector 128 on proximal housing 124 may be used for directinginsertion of the balloon with a guidewire, gas insufflation, opticalimaging, or the like.

A wide variety of alternative balloon configurations may be used. Forexample, a two-part balloon 130 may be filled in-part with a radiopaqueliquid 132, and in-part with a non-radiopaque gas or liquid 134, as canbe understood with reference to FIGS. 18A and B. Under remote imaging,gas 134 and liquid 132 may be easily distinguished to verify theorientation of the electrodes.

To enhance tissue contraction, it may be convenient to include a largernumber of electrodes on the least invasive probe structure. Typically,these electrodes will be arranged as alternating bipolar structures, ascan be understood with reference to FIGS. 19-20C. In some embodiments,the electrodes may be selectively energizable to vary the amount ofcontraction, and to direct the resistive heating to the target tissuewithout rotating the probe to a specific orientation. A barber poleballoon 140 having electrodes similar to the structure illustrated inFIG. 10 is shown in FIG. 19.

The balloon structures of the present invention need not necessarily beflat. For example, as illustrated in FIGS. 20A-C, a cylindrical balloon150 may be inflated to separate the fascia from the adjacent tissue, andto enhance engagement of at least some of the electrodes against thefascia. By selectively energizing the electrodes which engage theendopelvic fascia, collateral damage to the adjacent tissues may beavoided. As illustrated in FIG. 20C, cylindrical balloon 150 may bepartially deflated to avoid distention of the endopelvic fascia duringheating, and thereby enhance contraction. Such partial deflation mayalso increase the number of electrodes which engage the target tissue.

Still further alternative deployable electrode support structures areillustrated in FIGS. 21A-23C. For example, a self-spreading electrodesystem 160 includes a sheath 162 which restrains elongate first andsecond electrode support structures 164, 166. Once the self-spreadingsystem is positioned at the treatment site, sheath 162 is withdrawnproximally (or atraumatic tip 168 is advanced distally). The resilientsupport structures separate laterally when released from sheath 162,thereby deploying restrainable electrodes 170, 172. Optionally, a web171 between the electrodes limits the separation of the electrodes tothe desired distance. A similar deployable electrode structure mayinclude elongate electrode support structures which are nominallystraight, but which may be laterally displaced by a pull wire 174 todeploy the electrodes, as illustrated in FIGS. 22A-C.

Still further alternative deployable electrode structures are possible.As illustrated in FIGS. 23A-C, lateral deployment of flat electrodesupport structures 180 may be effected by drawing a middle member 182proximally. Fasteners 184 support the structures, and interact with aslot 186 in middle member 182 to limit axial movement of the middlemember and thereby control the spacing between the deployed electrodes.

As explained above, thermocouples or other temperature sensors may beincorporated into the least invasive probes of the present invention,preferably between the bipolar electrodes. Feedback control mayalternatively be provided by monitoring the energizing circuit, as wasalso explained above. Those of skill in the art will recognize thatballoon electrode support structures may make use of single lumen, ormultiple lumen shafts for inflation, energizing wires, temperaturesensing feedback, guidewires, gas or fluid insertion, and the like.

A grasping probe 190 is illustrated in FIG. 24. Grasping probe 190includes a pair of arms 192 which rotate about a hinge 194. Electrodes196 are disposed between arms 192 and oriented so as to engage thesurface of the tissue which is grasped by the arms.

A method for using grasping probe 190 is illustrated in FIGS. 25A and25B. In this embodiment, arms 192 engage abdominal fascia AF ofabdominal wall AW. Arms 192 grasp and draw a region of the tissue TRinward so as to reduce tension within the grasped region. Electrodes 196engage abdominal fascia AF within the tissue region TR, and a currentflux is directed between these electrodes to heat and shrink theabdominal fascia.

Preliminary work in connection with the present invention has shown thata wall stress of 1.3 lbs. per linear inch can limit the shrinkage ofsome fascia to about 20%, rather than the 40% to 50% shrinkage observedwhen that fascial tissue is not in tension. Hence, the methodillustrated in FIGS. 25A and 25B will find a variety of applications forshrinking tissues which would otherwise be under tension during theprocedure. Specifically, the illustrated method may be used duringabdominoplasty (sometimes referred to as a “tummy tuck”) to selectivelyshrink the abdominal wall. By reducing tension in the abdominal tissues,the shrinkage provided from the application of heating energy can beincreased significantly. Alternatively, the amount of area treated toprovide a particular reduction in length of the fascia can be minimized.If sufficient tissue is treated using such a method, the waistline ofthe patient could be reduced by several inches.

Grasping probe 190 may also be used in a wide variety of procedures, anda variety of grasping structures might be used, generally by grasping aregion of the tissue to be treated and pulling the region inward toeliminate and/or reduce tension in the grasped region. The graspedtissue should be free to shrink while grasped by the probe, and thefascia should be exposed for contact with the bipolar electrodes, orotherwise in a position to be heated by a heating element. In someembodiments, the grasped tissue may be heated by a laser, a monopolarradiofrequency electrode, a microwave antennae, focused ultrasoundtransducer, a heated probe surface, or the like. The grasped fascia maygenerally be heated by any heating element, and will shrink to a greaterextent than would otherwise result from heating tensioned fascia (orother collagenated tissue).

Grasping probe 190 may include a wide variety of alternative graspingstructures. In some embodiments, the ends of arms 192 may includeprotruding points to penetrate into and more firmly grip the fascia. Avacuum mechanism may be used to grasp the tissue region TR between thearms, or discrete vacuum ports on each arm might be used. Arms 192 mightslide (rather than pivot) relative to each other, and electrodes 196 maybe affixed to a single structure to maintain a predeterminedinterelectrode separation, and to limit tissue heating depth, asdescribed above.

The devices and methods of the present invention will find particularlyadvantageous applications for treatment of hernias, as can be generallyunderstood with reference to FIGS. 26 and 27. In FIG. 26, a portion of astomach ST protrudes through an enlarged esophageal hiatus EH of adiaphragm D. This can lead to severe reflux, in which the acidic stomachjuices are persistently regurgitated, eroding the wall of the esophagusand causing a burning pain. These symptoms are often aggravated by adefective lower esophageal sphincter LES. While such conditions may betreated using known methods, particularly using laparoscopic Nissenfundoplication, these surgical procedures require significant amounts ofsurgical experience and skill to be successful. Lack of experience inthese specialized procedures can lead to severe complications, includingpneumothorax, dysphagia, recurrent reflux, and loss of motility, therebymaking it difficult and/or impossible to eat. Hiatal hernias may includea tear in the diaphragm of between 1 and 5 cm adjacent hiatus EH.

To overcome these disadvantages, the hiatal hernia illustrated in FIG.26 may instead be treated by selectively shrinking the fascia ofdiaphragm D. Using the methods and devices of the present invention, thediameter of esophageal hiatus EH can be decreased so that the diaphragmproperly contains the stomach. Specifically, stomach ST is repositionedbelow diaphragm D, and grasping probe 190 (illustrated in FIG. 24)grasps the upper or lower surface of diaphragm D adjacent the esophagealhiatus. A portion of the diaphragm adjacent the esophageal hiatus isdrawn inward, preferably circumferentially so as to decrease the size ofthe hiatus. The fascia of diaphragm D may then be heated and contractedto prevent stomach ST from again protruding through the diaphragm.Alternatively, probe 10 (illustrated in FIG. 1), or any of thealternative tissue contracting structures described herein, might beused, particularly where diaphragm D is not under tension duringtreatment.

To improve the competence of lower esophageal sphincter LES, fasciaadjacent and external to the sphincter may be treated to close the valvemore effectively. In some embodiments, such as where a Nissen procedurewould normally be indicated, or where a reinforcing patch mightotherwise be placed over the defect to prevent recurrence of the hiatalhernia, the fascial covering of the top of the stomach SF and thecorresponding surface of the diaphragm SD may be treated to promote theformation of an adhesion between these surfaces (which will engage eachother once stomach ST is properly positioned below diaphragm D). Such anadhesion would decrease the likelihood of recurrence of the hiatalhernia, and may generally reinforce the defect.

A method for treating a hiatal hernia by forming a reinforcing adhesioncan be understood with reference to FIGS. 26A-26C. Stomach ST isdissected from the surrounding diaphragm D, with a dissected portion ofthe diaphragm DD often remaining affixed to the stomach by adhesions AD,as illustrated in FIG. 26A. The resulting enlarged hole in diaphragm Dis contracted by shrinking the collagenated diaphragm about the hole, asdescribed above and as illustrated in FIG. 26B. To secure stomach STbelow the contracted diaphragm, the adjacent surfaces of the stomach andthe diaphragm are treated to promote formation of an adhesion ADZconnecting these tissues. The dissected diaphragm segment DD aboutstomach ST may be removed to reduce necking, or may be left in place. Aprobe PR treating a superior surface of stomach ST is illustrated inFIG. 26C. It should be noted that the resulting 2 treated, opposedsurfaces will generally develop adhesions, while the treatment of onlyone of the opposed surfaces will not reliably promote adhesionformation. Once diaphragm D is contracted to properly size esophagealhiatus EH, and once adhesion ADZ connects the diaphragm to the stomach,reoccurrence of the hiatal hernia is substantially inhibited.

The methods and devices of the present invention are also suitable fortreatment of inguinal or abdominal hernias, as illustrated in FIG. 27.In inguinal hernia IH, a portion of the small intestine SI protrudesthrough the inguinal canal IC adjacent the spermatic cord SC. Using themethods of the present invention, the abdominal wall adjacent the deepinguinal ring DIR and/or adjacent the superficial inguinal ring SIR maybe selectively contracted about the spermatic cord once the smallintestine SI has been pushed back into the abdominal cavity. Selectiveshrinking of the fascial tissue about the spermatic cord will allow thefascial tissue to properly contain the abdominal organs, often withouthaving to resort to sutures, patches, and the like. Where the abdominalwall is not torn adjacent the hernia, treatment will often be possiblewithout grasping and drawing the tissue inward, as the stretched tissueshould not be under tension after the herniated bowel has beenrepositioned within the abdomen. Work in connection with the presentinvention has found that even hernias resulting in small tears of thefascial tissue can be corrected by shrinking using a laparoscopic probesimilar to that illustrated in FIG. 1. Preferably, such tears will beless than 2 cm in length, ideally being under 1 cm. In some embodiments,particularly where extended tears of the fascial tissue have been found,the selective shrinking of the present invention may be combined withsuturing, patches, and other known hernia repair techniques. Once again,where the abdominal wall is under tension during the treatmentprocedure, a grasping probe, such as that illustrated in FIG. 24, mightbe used to enhance the effective contraction of the abdominal wall.

Fascial tissue, once shrunk using the methods of the present invention,has nearly 20 times the strength needed to contain the intestines inplace. Nonetheless, to prevent the treated tissue from stretching ortearing during the healing process, a retention girdle RG may be worn.Retention girdle RG may help contain the tremendous forces generated bycoughing sneezing, and the like, particularly for a period of about 8weeks after a selectively shrinking of the fascia.

The present invention optionally relies on inducing controlled shrinkageor contraction of a tissue structure which comprises or supportsportions of the patient's urethra. The tissue structure will be one thatis responsible in some manner for control of urination and wherecontraction of the tissue structure will have the effect of reducingurinary leakage. Exemplary tissue structures include the urethral wall,the bladder neck, the bladder, the urethra, bladder suspensionligaments, the sphincter, pelvic ligaments, pelvic floor muscles,fascia, and the like. In one exemplary embodiment, a portion of theurethral wall at or near the urethral sling is heated to contract tissueand create a kink or crease in the wall which provides a preferentialclosure site for the urethra. In effect, it becomes easier for thepatient's weakened tissue support structures to close the urethra andmaintain continence. In another exemplary embodiment, the supportingtissues and ligaments are shortened to at least partially reverse thestretching and weakening that has resulted from pregnancy or otherpatient trauma. By selectively contracting one or more of thepubococcygeal, iliococcygeal and/or detrusor muscles, support of theureter and urinary sphincter can be substantially improved.

Tissue contraction results from controlled heating of the tissue byaffecting the collagen molecules of the tissue. Contraction may occur asa result of heat-induced uncoiling as the collagen β-pleated structureand subsequent re-entwinement as the collagen returns to bodytemperature. By maintaining the times and temperatures set forth below,significant tissue contraction can be achieved without substantialtissue necrosis.

While the remaining description is specifically directed at anenergy-applying probe introduced through the urethra of a femalepatient, it will be appreciated that the methods of the presentinvention can be performed with a variety of devices and systemsdesigned to deliver energy to tissue target sites resulting in heatingof the tissue and selective contraction of tissue support structures.The temperature of the target tissue structure can here be raised to avalue in the range from 70° C. to 95° C., for a time sufficient toeffect the desired tissue shrinkage. In these embodiments, thetemperature will be raised from ½ second to 4 minutes, optionally beingfrom 0.5 minutes to 4 minutes and often from 1 minute to 2 minutes. Thetotal amount of energy delivered will depend in part on which tissuestructure is being treated as well as the specific temperature and timeselected for the protocol. The power delivered will often be in therange from 1 W to 20 W, usually from 2 W to 5 W.

Referring now to FIG. 28, a heat-applying probe 210 comprises a probebody 212 having a distal end 214 and a proximal end 216. An electrode218 is disposed near the distal end 214 of the probe body 212 and isconnected via electrically conductive wires (not shown) extending thelength of the body and out through a connector cable 220 having a plug224 at its proximal end. Usually, a proximal handle or hub 226 isprovided at the proximal end 216 of the probe body 212. Conveniently,the hub 226 may include an arrow 228 indicating alignment of the probehub with the asymmetrically mounted electrode 218.

The electrode 218 is intended for delivering RF energy when attached toa power supply 230 (FIG. 30) connected through the plug 224 in cable220. As shown in FIGS. 28 and 30, the single electrode 218 is intendedfor monopolar operation. The electrode 218 may be formed from manyconventional electrically conductive electrode materials, such asstainless steel, platinum, conductive plastic, or the like. The probemay be formed from any conventional medical catheter or probe material,including organic polymers, ceramics, or the like. Usually, the probebody will be sufficiently flexible to be introduced through the urethrawith minimal discomfort, but it would also be possible to utilizesubstantially rigid probes as well.

The energy-applying probe 210 could also be adapted for bipolaroperation by including two or more isolated electrode surfaces near itsproximal end 218 (with electrically isolated conductors to each of theelectrode surfaces). As shown in FIG. 28B, a plurality of axiallyspaced-apart electrode surfaces 218 a, 218 b, 218 c, and 218 d could beconnected with an alternating polarity. Alternatively, as shown in FIG.28C, a plurality of circumferentially spaced-apart electrodes 218 e, 218f, 218 g, and 218 h could also be connected with alternating polarity.Usually, each of the electrodes will be connected through the probe body212 by a single isolated wire or other conductor, terminating in theconnector plug 224. Thus, the multiple electrode configurations of FIGS.28B and 28C can be operated either in a monopolar or bipolar fashion,depending on how the power supply is configured.

A particular electrode configuration including a pair of axiallyspaced-apart electrodes 218 i and 218 j is illustrated in FIG. 28D. Thiselectrode configuration is intended for treating the urethral wall atlocations immediately upstream and downstream of the urethral sling.Typically, the electrodes will be spaced-apart by distance in the rangefrom 1 mm to 5 mm, preferably from 1.5 mm to 3 mm.

In all the electrode configurations of FIGS. 28-28D, the total electrodearea will usually be in the range from 1 mm² to 10 mm², preferably from2 mm² to 6 mm². Moreover, the electrodes will be configured to reduce oreliminate electrical current concentrations when operating in a radiofrequency mode. Usually, the electrode surfaces will be relativelysmooth, and the edges will be insulated or protected by the adjacentprobe body 212. In this way, the electric field or flux emanating fromthe electrodes 218 will be relatively uniform, resulting in generallyeven heating of the tissue which is contacted by the electrode.

A further exemplary electrode embodiment is shown in FIG. 29. There, aplurality of circumferentially spaced-apart electrodes 230 are mountedon an inflatable balloon 232 at the distal end 234 of an energy-applyingprobe 236. Each of the electrodes 230 will be connected to a single orto multiple conductors running to the proximal end (not shown) of theenergy-applying probe 236, in a manner similar to that illustrated forprobe 210. By mounting the electrodes 230 on a radially expandableballoon or other expansion member (e.g., an expandable cage), theelectrodes can be firmly contacted against an interior surface of theurethra. Moreover, the contact can be maintained as the urethral wallexpands or contracts, depending on how the energy is applied.

Referring now to FIG. 30, use of the energy-applying probe 210 fortreating a target site TS in a urethra draining bladder B isillustrated. The probe 210 is inserted so that electrode 218 contactsthe target site TS, which is typically adjacent the urethral sling. Theelectrode may be positioned based on ultrasonic imaging, fluoroscopicimaging, or the like. Alternatively, the probe may be inserted to aknown depth using a scale formed on the exterior of the probe (notshown). After properly positioning the electrode 218, RF energy isapplied from power supply 230 typically at a level in the range from 1 Wto 20 W, usually from 2 W to 5 W. As illustrated, the electrode 218 is amonopolar electrode, and a counter electrode 240 will be attached to anexternal portion of the patient's skin. The counter electrode isconnected to the power supply 230 by an appropriate cable 242 and plug244. Energy is applied until the tissue temperature is reached andmaintained for a desired amount of time. Optionally, a temperaturesensor can be provided on the probe 210, and feedback control of theamount of energy being applied can be implemented. For example, athermal couple, a thermistor, or other temperature sensor can be mountedadjacent to or within the electrode 218. Alternatively, a penetratingelement (not shown) can be provided on the probe to enter beneath thesurface of the urethral wall by a pre-selected distance to measureinternal tissue temperature. Other known temperature control techniquescould also be utilized.

Referring now to FIGS. 31-33, a heat-applying probe 400 comprises aprobe body having a sheath component 402 and an electrode rod component404. The electrode rod 404 is reciprocatably mounted in a lumen of thesheath 403 so that a distal electrode array 406 on the rod 404 may beretracted and extended into and from the distal end 408 of the sheath402. A proximal handle 410 is provided on the sheath, and a proximalconnector 412 is provided on the electrode rod component 404.

The electrode array 406, as illustrated, includes four individualelectrode tips 420 each of which has a sharpened distal end suitable forpenetrating into tissue, particularly for transmucosal penetrationthrough the vaginal wall into the tissue structures which support theurethra or urinary sphincter. The electrode tips 420 are sufficientlyresilient so that they will be radially contracted when the rod 404 iswithdrawn proximally into the sheath 408. The electrode tips 420 willresiliently expand from the sheath when the electrode rod component 404is advanced distally when the sheath 408 is positioned near the tissuetarget site, as discussed in more detail below. As illustrated, theelectrode tips 420 are commonly connected to a single plug in theconnector 412. Thus, the probe 400 is only suitable for monopolaroperation. It will be appreciated, however, that the multiple electrodetips 420 could be connected through separate, isolated conductors withinthe rod 404 and further be connected through multiple pins in theconnector 412. Thus, the probe 400 could readily be adapted for bipolaroperation. Usually, all components of the probe will be insulated, otherthan the electrode tips 420. Alternatively, some other portion of therod 404 or sheath 402 could be formed from electrically conductivematerial and utilized as a common or indifferent electrode so that theprobe could be utilized in a bipolar manner. A variety of suchmodifications would be possible with the basic probe design.

Referring now to FIGS. 34-37, use of probe 400 for contracting tissueligaments which support the urethra in the region of the urethral slingwill be described. Initially, the treating physician manually examinesthe vagina V to locate the region within the vagina beneath the urethralsling. The probe 400 is then introduced into the vagina. Conveniently,the physician may manually locate the probe, again by feeling the regionwhich is supported by the urethral sling. After the sheath 402 of theprobe 400 is properly positioned, the rod component 404 will be distallyadvanced so that the electrode tips 420 are penetrated into the tissuewhich supports the urethra, typically the pubococcygeal muscles,iliococcygeal muscles or the detrusor muscle as illustrated in FIGS. 36and 37. The physician will continue to use a finger F to hold the probeagainst the vaginal wall to facilitate penetration of the electrode tips420. RF energy can then be applied through the probe in order to heatthe target tissue to temperatures and for time periods within the rangesset forth above. The supporting tissues are thus contracted in order toreduce urinary leakage and enhance patient continence.

The procedures of the present invention result in bulking andbuttressing of the supporting tissue structures as the tissue heal. Thisresult is in addition to the tissue contraction, with both thecontraction and tissue bulking/buttressing acting to enhance patientcontinence.

Referring now to FIG. 38, a kit 500 includes a tissue contracting probe502 and instructions for its use 504. Contracting probe 502 andinstructions 504 are disposed in packaging 506. Contracting probe 502here includes a structure similar to probe 10 of FIG. 1, but has aradially ended tip 54 to facilitate laparoscopically engaging theelectrode wires against both laterally and axially oriented tissues.Instructions 504 will often set forth the steps of one or more of themethods described herein above for treating urinary incontinence.Additional elements of the above-described systems may also be includedin packaging 506, or may alternatively be packaged separately.

Instructions 504 will often comprise printed material, and may be foundin whole or in part on packaging 506. Alternatively, instructions 504may be in the form of a recording disk or other computer-readable data,a video tape, a sound recording, or the like.

The present invention further encompasses methods for teaching theabove-described methods by demonstrating the methods of the presentinvention on patients, animals, physical or computer models, and thelike.

While the exemplary embodiment has been described in some detail, by wayof illustration and for clarity of understanding, various modifications,adaptations, and changes will be obvious to those of skill in the art.Therefore, the scope of the present invention is limited solely by theappended claims.

What is claimed is:
 1. A probe for heating and contracting fascia, theprobe comprising: a rigid shaft having a proximal end and a distal endwith a probe surface disposed near the distal end; first and secondelongate electrodes disposed along the probe surface, wherein eachelectrode has a rounded electrode surface protruding from the probesurface so that each electrode, in a cross-section across the elongateelectrodes, has a tissue-engaging surface diameter between about 0.25and 4 mm, and wherein the first and second electrodes are simultaneouslyerigageable against the fascia while a bipolar current flowstherebetween to provide heating and contraction of the fascia, the firstand second electrodes being laterally off-set so that thetissue-engaging surface diameters in the cross-section are separated bya separation distance of between about 1 and 4 times the electrodesurface diameters so as to limit a depth of tissue heating; and a handleadjacent the proximal end of the shaft for manipulating the electrodes.2. A probe as claimed in claim 1, further comprising a battery mountedto the handle and circuitry coupled to the battery for energizing theelectrodes with RF energy to heat the fascia.
 3. A probe as claimed inclaim 1, further comprising a sensor disposed between the electrodes tomeasure a temperature of the fascia, and a control system coupled to theelectrodes and the sensor to limit the temperature of the heated fasciabelow about 110° C.
 4. A probe as claimed in claim 1, wherein the firstand second electrodes are adapted for sweeping over the fasciasimultaneously.
 5. A probe for heating and contracting a target tissueof a patient body, the probe comprising: a rigid shaft having a proximalend and a distal end with a probe surface near the distal end; at leastone elongate electrode defining an electrode axis and disposed near thedistal end of the shaft, the at least one electrode protruding laterallyfrom the probe surface along the electrode axis and having a roundedsurface with a tissue-engaging surface diameter, across said electrodeaxis, of between about 0.25 mm and 4 mm to limit a depth of tissueheating; and a handle adjacent a proximal end of the shaft to manipulatethe at least one electrode from outside the patient body, the handlesupporting a battery and circuitry which energizes the at least oneelectrode with RF power at a level for heating and contracting thetarget tissue without substantially ablating the target tissue.
 6. Aprobe as claimed in claim 5, further comprising a temperature sensordisposed near the distal end of the shaft to monitor a temperature ofthe target tissue.
 7. A probe as claimed in claim 6, wherein thetemperature sensor and the electrode are coupled to a circuit whichcontrols RF power supplied to the electrode by the battery pack.
 8. Aprobe as claimed in claim 7, wherein the temperature sensor is mountedbetween two bipolar electrodes of the probe.
 9. A probe as claimed inclaim 5, further comprising two bipolar elongate electrodes protrudinglaterally from the probe surface and having rounded surfaces withtissue-engaging surface diameters of between about 0.25 and 1.0 mm, theaxes of the electrodes being laterally offset along the probes surfacesuch that the electrodes are separated by between about 0.25 and 4.0 mm.10. A probe for heating and contracting fascia, the probe comprising: arigid probe body with a probe surface; a first elongate electrode havinga first axis extending along the probe surface, the first electrodeprotruding laterally from the probe surface relative to the first axisso as to present a first tissue-engaging electrode surface with a firstsurface diameter of between 0.25 and 4 mm; a second elongate electrodehaving a second axis extending along the probe surface, the secondelectrode protruding laterally from the probe surface relative to thesecond axis so as to present a second tissue-engaging electrode surfacewith a second surface diameter of between 0.25 and 4 mm, the first andsecond electrode offset laterally with a separation distance of betweenabout 1 and 4 times each electrode surface diameter so as to limit adepth of tissue heating; a handle adjacent the proximal end of the shaftfor manipulating the electrodes; and a control system coupled to theelectrodes so as to limit a temperature of the heated fascia below about110° C.
 11. A probe as claimed in claim 10, wherein the probe surface iscurved so that the axes comprise curved lines.